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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K171819
Device Name Attain Assist CS Access Catheter
Applicant
Creganna Medical Also Doing Business AS Ceganna Tactx Medica
Parkmore W.
Galway,  IE
Applicant Contact Olivia Odhiambo
Correspondent
Creganna Medical Also Doing Business AS Ceganna Tactx Medica
Parkmore W.
Galway,  IE
Correspondent Contact Olivia Odhiambo
Regulation Number870.1250
Classification Product Code
DQY  
Date Received06/19/2017
Decision Date 01/04/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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